Monday, November 08, 2010

I've had a number of conversations in the last few weeks that have all led me to the same conclusion: It really does make sense to "follow the money" when it comes to evaluating the claims of various experts. It's not that an expert deliberately misleads or lies due to funding sources. Rather, the advice the expert provides may be skewed by--he or she may be rendered ignorant as a result of--funding sources (or the lack thereof).

This idea came up most recently just yesterday, at lunch.

One of my family members commented that medical doctors, in general, are ignorant about a lot of the impact of diet on health (i.e., they don't "even" recognize diseases or disease conditions caused by inappropriate diet and/or diseases or disease conditions that are only treatable by change in diet) . . . because . . . well, there is no money in it for them.

And that's not to say they are "only in it [medicine] for the money." Rather, that's to acknowledge that . . .

The entire conventional medical (allopathic medical) approach--believed in and practiced by the doctors and their staffs, and believed in and pursued by their patients--has to do with diagnosing a condition that can be "fixed" ("healed") by a medicine and/or procedure. . . . If there is no known prescribable medicine and/or procedure, then . . . well, . . .

The doctor has failed to fulfill his patient's expectations. ("You're supposed to have a prescription for this! A nostrum! A medication! A 'magic bullet' that takes care of these kinds of problems! . . . You're supposed to be able to 'fix' me! . . . I shouldn't have to change my lifestyle in order to 'fix myself'!")

There are so many conditions for which the medical doctor does have a medication he or she can prescribe, why would he or she waste the time studying conditions that don't match that model?

But even prior to the doctor's motivations and/or incentives,

What's in it for pharmaceutical companies . . . or food companies, for that matter . . . to study dietary solutions? Foods, in general, are non-patentable. So to discover that cherries, for instance, reduce inflammation: who is going to pay for the research and/or pay to ensure medical students are taught about cherries' unique healing attributes?

More or less saying what I have just said, but from a different angle:

With no financial incentives, the pharmaceutical industry isn't going to ensure physicians are instructed about the benefits of dietary changes. Rather, their incentives are all aligned with ignoring diet and, rather, producing, distributing and marketing more drugs.

Even, interestingly, the FDA--what should be a neutral "policeman" in this arena--is financially incentivized to promote drugs and ignore--or, actually, discriminate against dietary solutions to disease.

How and why is this the case?

Drug manufacturers have to invest millions--indeed, we are given to believe, normally hundreds of millions--of dollars to jump through all the hoops of a New Drug Application required for FDA approval of any drug "made by a different manufacturer, [that] uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change" from those already on the market.

And you are probably thinking, "So what does that have to do with dietary solutions to disease?"

Well, as numerous companies and food trade groups have discovered to their own dismay, "If you dare discuss the health benefits of any food or natural substance while you are selling such items, you will be branded a criminal by the FDA, threatened with criminal prosecution and potentially have your company raided by the FDA along with armed law enforcement agents with guns drawn." (Check out FDA censorship of nutritional science threatens health of all Americans for a broad overview. But for more specific examples of what I'm talking about, see the story about Diamond Foods and what happened when it attempted to promote the health benefits of walnuts. Or the story of the FDA as it came against marketers of cherries who referenced and/or linked to scientific studies that described health benefits of cherries.)

Because Mike Adams, the author of the articles I have just referenced, sometimes states his case in a deliberately provocative manner, let me link to a few typical warning letters from the FDA, so you can see how they phrase things.

Check out, for example, this letter to Payson Fruit Growers of Payson, Utah, or to Cherry Lands Best of Appleton, Wisconsin. --Or take a look at any of the dozens of similar "Labeling and Promotional Violations" letters on the FDA website. --October 17, 2005 was a good date for cherry marketers.

As the letters explain, under the Federal Food, Drug, and Cosmetic Act, "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs" and any health claims made for any product "cause [such] product to be a drug."

Because [cherries, walnuts, or whatever food are] not generally recognized as safe and effective when used as labeled, [they are] also . . . new drug[s] as defined in Section 201(p) of the Act [21 U.S.C. 321(p)]. Under Section 505 of the Act (21 U.S .C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).

But this is not only an issue when it comes to foods--as our family was discussing yesterday.

It comes out in areas like farming and gardening as well.

Several weeks ago, one of my brothers raised questions about International Ag Labs, the soils testing and amendment recommending company whose services we have chosen as we seek to improve the soil on our prospective farm and in our garden. He referenced a post by a skeptical Extension Specialist in Urban Horticulture.

The initial post is mildly critical of IAL and, as I said, it is clearly skeptical. But it sounds relatively open-minded. As happens so often with some blogs, however, fireworks begin to explode in the comments afterward (including what the blogger herself, Dr. Linda Chalker-Scott, says).

Several IAL clients respond: "Look at the results! Here's my story!"

Chalker-Scott and other skeptics reply, "That's not science." And, as she notes (February 23, 2010):

My job - and the job of ANY university extension specialist - is to provide science-based information to the public. . . . What you won't find from university scientists, including extension specialists like myself, is a promotion of products or practices with no basis in science.

Subsequent discussion is then comprised primarily of further testimonials . . .

"Dear Linda, I have run over 600 soil tests through IAL in the past 4 years. I have a very successful business that has been serving our community for over 55 years. We used other labs here in California with very poor results. I will say with out a doubt that the information that comes from IAL is remarkable and has help my business grow because of the results." --George Schnackenberg.

Or,

"I am an amateur gardener. I tried IAL last year and had the joy of tasting some of the most amazing vegetables. For example, broccoli that was actually sweet like carrots." --Nick.

And,

"I'm a small market farmer not a scientist. IAL's recommendations worked for me. I used the [products IAL recommended]. My pluots averaged 20-22 Brix. You can't argue with results. It is my understanding that [the materials work in the following way. However,] I don't have to know exactly how it works I just know it works." --Jeannie.

Etc.

. . . and Chalker-Scott and one of her cohorts replying (in three separate comments dated February 25, 2010) with,

"I'm sorry, but if you want me (or any other scientist) to be convinced of a particular viewpoint, then support it with published, peer-reviewed data. That's the way science works. If you don't like the accepted paradigm, then don't use it. But don't expect scientists to take you seriously.

"I'm happy to hear that your garden is doing well, but the fact that you followed IAL's recommendations does not prove that those recommendations are any better than the recommendations from another lab. Furthermore, it's possible that, by using IAL's recommendations, you overfertilized making your plants look good but poisoning the environment. To test these possibilities side by side studies need to be conducted. Without studies like these we're left with anecdotal evidence which carries little weight. Once again, show us the science which proves IAL gives recommendations which are better than other labs -- show us evidence supporting the wacky things they seem to be recommending -- We won't be changing our minds without that kind of data."

Things get a bit nasty (or, shall we say, at least testy) as the IAL promoters tell their stories and charge the scientists with being closed-minded and--not quite in so many words, but, in essence--being toadies to and fools for "big ag" corporations like Monsanto. And the scientists respond with increasing exasperation at what they perceive as unfair charges.

I don't want to get sidelined with a discussion about methods of "argumentation" (or, in far too many cases, presentation--since, too often, the anti-professorial disputants present no real arguments but, instead, "simply" spew venom). People like "The Justin" are merely embarrassing. And especially so when put up against Chalker-Scott's astonishingly gracious response to a wholly obnoxious and venomous diatribe.

In an October 13 post she admits, "I’m angry. Really, really angry. . . . [And] this is why I’m mad. There’s widespread perception among nonacademic types that corporate grant money “buys” results. That’s insulting. Most scientists do what they do because they love the thrill of discovery. There’s no thrill if you’ve rigged the results. Moreover, if you rig the results you’re going to be found out . . . eventually."

After reading Linda’s excellent post yesterday I got to thinking about all of the discussions I have had over the years with people who didn’t know or understand where we (and by we, I mean my research group) got the money to do the work which we do. Oh, they thought they knew, but they were usually way, way off.

So he then lists five sources:

Endowment (a sizable fund whose earnings are used to underwrite a professor's salary, research expenses, etc.).

Hard ("fixed") funding from the university (to enable a professor to pursue research in line with his or her area of expertise).

Gifts (one-time presents of money).

Government Grant.

Industry Grant ("similar to a Government Grant except that it is given by an industry group, such as the Minnesota Turf and Grounds Foundation, or by a particular company, such as Bayer. Industry groups are a preferred source of income, [because] money from chemical companies, and other independent companies, does have a little bit of a stigma associated with it – it feels like you’re doing something to benefit one company instead of society as a whole. Chemical company money is not sneered at, but often you do have to conduct research that may not be at the top of your priority list").

As for conflicts of interest:

I’d like to conclude by saying that, in the case of dollars from chemical companies, I don’t personally know of any researcher who has purposefully falsified, failed to report, skewed, or selectively excluded data to make the chemical company happier with the results. Doing so would ultimately just make that researcher (and the chemical company) look like an idiot.

I have personally given data to chemical companies which shows that their stuff doesn’t work that well – they don’t like it, but they appreciate it – marketing something that doesn’t work isn’t good for anyone. I do know of a case where a researcher proposed a study to a large chemical company which would examine unseen dangers of a particular pesticide and was turned down – this was disappointing to me. I think that many companies feel that they have a duty to seek out obvious dangers and that the government has a responsibility to fund research investigating unseen or unlikely dangers – but that’s just my own opinion.

My thought: I don't think these professors--or 99.9% of all professors or researchers--engage in any purposefully misleading, fraudulent, or, as Chalker-Scott describes it, "rigged" research. They would be and/or are genuinely horrified to find themselves being charged with acting as shills for big-ag chemical companies like Monsanto.

However, I think Chalker-Scott and Gillman somehow forget the golden rule that "He who has the gold makes the rules." And the "rules" that companies like Monsanto are able to establish include prescriptions of what will be studied (not the specific results that a researcher is to arrive at, but, "simply," the subject matter itself). Companies like Monsanto have enough potential profit to make if a study turns their way, and/or, they believe they can gain enough social capital by funding certain relatively innocuous studies, that . . . it behooves them to fund such studies.

For research projects that could prove wonderfully profitable if it goes "right" (or terribly destructive to the sponsor's bottom line if it goes "wrong"), the sponsor need "merely" track the project as it goes forward. And if it appears test results are heading in the "wrong" direction for the company's interests, the company need "merely" terminate the research and/or deep-six the results.

We'll talk more about some of those kinds of situations in "Follow the money, Part 2."

Meanwhile, organizations like International Ag Labs that have no patentable products that could potentially gain traction in the marketplace if certain research projects turned out in their favor: what incentives do they have to sponsor the kind of research that Chalker-Scott and her cohorts demand?

I've had a number of conversations in the last few weeks that have all led me to the same conclusion: It really does make sense to "follow the money" when it comes to evaluating the claims of various experts. It's not that an expert deliberately misleads or lies due to funding sources. Rather, the advice the expert provides may be skewed by--he or she may be rendered ignorant as a result of--funding sources (or the lack thereof).

This idea came up most recently just yesterday, at lunch.

One of my family members commented that medical doctors, in general, are ignorant about a lot of the impact of diet on health (i.e., they don't "even" recognize diseases or disease conditions caused by inappropriate diet and/or diseases or disease conditions that are only treatable by change in diet) . . . because . . . well, there is no money in it for them.

And that's not to say they are "only in it [medicine] for the money." Rather, that's to acknowledge that . . .

The entire conventional medical (allopathic medical) approach--believed in and practiced by the doctors and their staffs, and believed in and pursued by their patients--has to do with diagnosing a condition that can be "fixed" ("healed") by a medicine and/or procedure. . . . If there is no known prescribable medicine and/or procedure, then . . . well, . . .

The doctor has failed to fulfill his patient's expectations. ("You're supposed to have a prescription for this! A nostrum! A medication! A 'magic bullet' that takes care of these kinds of problems! . . . You're supposed to be able to 'fix' me! . . . I shouldn't have to change my lifestyle in order to 'fix myself'!")

There are so many conditions for which the medical doctor does have a medication he or she can prescribe, why would he or she waste the time studying conditions that don't match that model?

But even prior to the doctor's motivations and/or incentives,

What's in it for pharmaceutical companies . . . or food companies, for that matter . . . to study dietary solutions? Foods, in general, are non-patentable. So to discover that cherries, for instance, reduce inflammation: who is going to pay for the research and/or pay to ensure medical students are taught about cherries' unique healing attributes?

More or less saying what I have just said, but from a different angle:

With no financial incentives, the pharmaceutical industry isn't going to ensure physicians are instructed about the benefits of dietary changes. Rather, their incentives are all aligned with ignoring diet and, rather, producing, distributing and marketing more drugs.

Even, interestingly, the FDA--what should be a neutral "policeman" in this arena--is financially incentivized to promote drugs and ignore--or, actually, discriminate against dietary solutions to disease.

How and why is this the case?

Drug manufacturers have to invest millions--indeed, we are given to believe, normally hundreds of millions--of dollars to jump through all the hoops of a New Drug Application required for FDA approval of any drug "made by a different manufacturer, [that] uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change" from those already on the market.

And you are probably thinking, "So what does that have to do with dietary solutions to disease?"

Well, as numerous companies and food trade groups have discovered to their own dismay, "If you dare discuss the health benefits of any food or natural substance while you are selling such items, you will be branded a criminal by the FDA, threatened with criminal prosecution and potentially have your company raided by the FDA along with armed law enforcement agents with guns drawn." (Check out FDA censorship of nutritional science threatens health of all Americans for a broad overview. But for more specific examples of what I'm talking about, see the story about Diamond Foods and what happened when it attempted to promote the health benefits of walnuts. Or the story of the FDA as it came against marketers of cherries who referenced and/or linked to scientific studies that described health benefits of cherries.)

Because Mike Adams, the author of the articles I have just referenced, sometimes states his case in a deliberately provocative manner, let me link to a few typical warning letters from the FDA, so you can see how they phrase things.

Check out, for example, this letter to Payson Fruit Growers of Payson, Utah, or to Cherry Lands Best of Appleton, Wisconsin. --Or take a look at any of the dozens of similar "Labeling and Promotional Violations" letters on the FDA website. --October 17, 2005 was a good date for cherry marketers.

As the letters explain, under the Federal Food, Drug, and Cosmetic Act, "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs" and any health claims made for any product "cause [such] product to be a drug."

Because [cherries, walnuts, or whatever food are] not generally recognized as safe and effective when used as labeled, [they are] also . . . new drug[s] as defined in Section 201(p) of the Act [21 U.S.C. 321(p)]. Under Section 505 of the Act (21 U.S .C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).

But this is not only an issue when it comes to foods--as our family was discussing yesterday.

It comes out in areas like farming and gardening as well.

Several weeks ago, one of my brothers raised questions about International Ag Labs, the soils testing and amendment recommending company whose services we have chosen as we seek to improve the soil on our prospective farm and in our garden. He referenced a post by a skeptical Extension Specialist in Urban Horticulture.

The initial post is mildly critical of IAL and, as I said, it is clearly skeptical. But it sounds relatively open-minded. As happens so often with some blogs, however, fireworks begin to explode in the comments afterward (including what the blogger herself, Dr. Linda Chalker-Scott, says).

Several IAL clients respond: "Look at the results! Here's my story!"

Chalker-Scott and other skeptics reply, "That's not science." And, as she notes (February 23, 2010):

My job - and the job of ANY university extension specialist - is to provide science-based information to the public. . . . What you won't find from university scientists, including extension specialists like myself, is a promotion of products or practices with no basis in science.

Subsequent discussion is then comprised primarily of further testimonials . . .

"Dear Linda, I have run over 600 soil tests through IAL in the past 4 years. I have a very successful business that has been serving our community for over 55 years. We used other labs here in California with very poor results. I will say with out a doubt that the information that comes from IAL is remarkable and has help my business grow because of the results." --George Schnackenberg.

Or,

"I am an amateur gardener. I tried IAL last year and had the joy of tasting some of the most amazing vegetables. For example, broccoli that was actually sweet like carrots." --Nick.

And,

"I'm a small market farmer not a scientist. IAL's recommendations worked for me. I used the [products IAL recommended]. My pluots averaged 20-22 Brix. You can't argue with results. It is my understanding that [the materials work in the following way. However,] I don't have to know exactly how it works I just know it works." --Jeannie.

Etc.

. . . and Chalker-Scott and one of her cohorts replying (in three separate comments dated February 25, 2010) with,

"I'm sorry, but if you want me (or any other scientist) to be convinced of a particular viewpoint, then support it with published, peer-reviewed data. That's the way science works. If you don't like the accepted paradigm, then don't use it. But don't expect scientists to take you seriously.

"I'm happy to hear that your garden is doing well, but the fact that you followed IAL's recommendations does not prove that those recommendations are any better than the recommendations from another lab. Furthermore, it's possible that, by using IAL's recommendations, you overfertilized making your plants look good but poisoning the environment. To test these possibilities side by side studies need to be conducted. Without studies like these we're left with anecdotal evidence which carries little weight. Once again, show us the science which proves IAL gives recommendations which are better than other labs -- show us evidence supporting the wacky things they seem to be recommending -- We won't be changing our minds without that kind of data."

Things get a bit nasty (or, shall we say, at least testy) as the IAL promoters tell their stories and charge the scientists with being closed-minded and--not quite in so many words, but, in essence--being toadies to and fools for "big ag" corporations like Monsanto. And the scientists respond with increasing exasperation at what they perceive as unfair charges.

I don't want to get sidelined with a discussion about methods of "argumentation" (or, in far too many cases, presentation--since, too often, the anti-professorial disputants present no real arguments but, instead, "simply" spew venom). People like "The Justin" are merely embarrassing. And especially so when put up against Chalker-Scott's astonishingly gracious response to a wholly obnoxious and venomous diatribe.

In an October 13 post she admits, "I’m angry. Really, really angry. . . . [And] this is why I’m mad. There’s widespread perception among nonacademic types that corporate grant money “buys” results. That’s insulting. Most scientists do what they do because they love the thrill of discovery. There’s no thrill if you’ve rigged the results. Moreover, if you rig the results you’re going to be found out . . . eventually."

After reading Linda’s excellent post yesterday I got to thinking about all of the discussions I have had over the years with people who didn’t know or understand where we (and by we, I mean my research group) got the money to do the work which we do. Oh, they thought they knew, but they were usually way, way off.

So he then lists five sources:

Endowment (a sizable fund whose earnings are used to underwrite a professor's salary, research expenses, etc.).

Hard ("fixed") funding from the university (to enable a professor to pursue research in line with his or her area of expertise).

Gifts (one-time presents of money).

Government Grant.

Industry Grant ("similar to a Government Grant except that it is given by an industry group, such as the Minnesota Turf and Grounds Foundation, or by a particular company, such as Bayer. Industry groups are a preferred source of income, [because] money from chemical companies, and other independent companies, does have a little bit of a stigma associated with it – it feels like you’re doing something to benefit one company instead of society as a whole. Chemical company money is not sneered at, but often you do have to conduct research that may not be at the top of your priority list").

As for conflicts of interest:

I’d like to conclude by saying that, in the case of dollars from chemical companies, I don’t personally know of any researcher who has purposefully falsified, failed to report, skewed, or selectively excluded data to make the chemical company happier with the results. Doing so would ultimately just make that researcher (and the chemical company) look like an idiot.

I have personally given data to chemical companies which shows that their stuff doesn’t work that well – they don’t like it, but they appreciate it – marketing something that doesn’t work isn’t good for anyone. I do know of a case where a researcher proposed a study to a large chemical company which would examine unseen dangers of a particular pesticide and was turned down – this was disappointing to me. I think that many companies feel that they have a duty to seek out obvious dangers and that the government has a responsibility to fund research investigating unseen or unlikely dangers – but that’s just my own opinion.

My thought: I don't think these professors--or 99.9% of all professors or researchers--engage in any purposefully misleading, fraudulent, or, as Chalker-Scott describes it, "rigged" research. They would be and/or are genuinely horrified to find themselves being charged with acting as shills for big-ag chemical companies like Monsanto.

However, I think Chalker-Scott and Gillman somehow forget the golden rule that "He who has the gold makes the rules." And the "rules" that companies like Monsanto are able to establish include prescriptions of what will be studied (not the specific results that a researcher is to arrive at, but, "simply," the subject matter itself). Companies like Monsanto have enough potential profit to make if a study turns their way, and/or, they believe they can gain enough social capital by funding certain relatively innocuous studies, that . . . it behooves them to fund such studies.

For research projects that could prove wonderfully profitable if it goes "right" (or terribly destructive to the sponsor's bottom line if it goes "wrong"), the sponsor need "merely" track the project as it goes forward. And if it appears test results are heading in the "wrong" direction for the company's interests, the company need "merely" terminate the research and/or deep-six the results.

We'll talk more about some of those kinds of situations in "Follow the money, Part 2."

Meanwhile, organizations like International Ag Labs that have no patentable products that could potentially gain traction in the marketplace if certain research projects turned out in their favor: what incentives do they have to sponsor the kind of research that Chalker-Scott and her cohorts demand?